Predictors of recurrence after paclitaxel drug-coated balloon use for treating femoropopliteal in-stent restenosis

Ashraf Gamal Taha; Mahmoud Ismael Saleh; Haitham Ali; Walid M Gamal

doi:10.1177/17085381231162123

Predictors of recurrence after paclitaxel drug-coated balloon use for treating femoropopliteal in-stent restenosis

Vascular. 2023 Mar 10:17085381231162123. doi: 10.1177/17085381231162123. Online ahead of print.

Authors

Ashraf Gamal Taha¹, Mahmoud Ismael Saleh¹, Haitham Ali¹, Walid M Gamal²

Affiliations

¹ Department of Vascular and Endovascular Surgery, 68796Assiut University Hospital, Assiut, Egypt.
² Qena Vascular Surgery Department, 68898South Valley University, Qena, Egypt.

PMID: 36896828
DOI: 10.1177/17085381231162123

Abstract

Objective: Paclitaxel drug-coated balloon (PDCB) angioplasty has been shown to be an effective treatment of in-stent restenosis (ISR) at the femoropopliteal (FP) arteries. Long-term studies, however, have shown a progressive decrease in the patency rates following PDCB. The aim of this study was to determine the predictors of stenosis recurrence after PDCB treatment of FP-ISR, and its immediate and mid-term outcomes.

Methods: This prospective, non-randomized study included all chronic lower extremity ischemia patients of Rutherford class 3-6 who underwent PDCB angioplasty to treat >50% FP-ISR between June 2017 and December 2019. The primary endpoint was primary patency, defined as freedom from binary restenosis and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months. Secondary endpoints included 12-months freedom from CD-TLR and major adverse events (MAEs).

Results: A total of 73 symptomatic chronic limb ischemia patients (73 limbs including 63 with limb threatening ischemia) underwent PDCB angioplasty of FP-ISR lesions (13.7% Tosaka class I, 54.8% class II, and 31.5% class III). The mean ISR lesion length was 121.8 ± 52.7 mm. Technical success was achieved in 70 (95.9%) patients. Kaplan-Meier estimate of the 12-months rates of primary patency and freedom from CD-TLR was 76.1% and 87.4%, respectively. At one year, MAEs occurred in eight patients (11.0%) including two deaths (2.7%), one major amputation (1.4%), and six (8.2%) surgical revascularizations. Multivariable analysis showed that Tosaka class III ISR (HR 4.51, CI: 1.31-15.53, p < 0.001) and reference vessel diameter (HR 0.38, 95% CI: 0.18-080, p = 0.01) were independently associated with recurrent ISR.

Conclusions: PDCB is safe and effective treatment of FP-ISR lesions. Occlusive ISR lesions and reference vessel diameter were independently associated with recurrent ISR stenosis after PDCB treatment.

Keywords: In-stent restenosis; drug-eluting balloon; femoropopliteal arteries; paclitaxel drug-coated balloon; peripheral arterial disease.